Tag Archives: diabetes

When it comes to finding treatments and cures for complicated conditions such as diabetes, why not cast the widest net possible for new ideas? That’s the thinking behind the Juvenile Diabetes Research Foundation’s new collaboration with an organization called Innocentive to seek innovative proposals from the general public for a novel glucose-responsive insulin drug. The “Challenge,” which offers a $100,000 reward, is an example of crowdsourcing in drug discovery, a recent concept that has been gaining momentum.

manbeastextraordinaire (Jake Brown) / Wikimedia Commons

“Originally, crowdsourcing was defined as a mechanism by which specific problems are communicated to an unknown group of potential solvers in the form of an open call, usually via the Internet; the community (the “crowd”) is asked to provide solutions and the ‘winners’ are rewarded,” Dr. Monika Lessl and Dr. Khusssru Asadullah, of Global Drug Discovery Bayer Healthcare Pharmaceuticals, Berlin, wrote earlier this year in Nature Reviews/Drug Discovery.

Eli Lilly was the first company to introduce the crowdsourcing concept in drug discovery by establishing the InnoCentive platform in 2001. Now an independent organization, InnoCentive has a “solver” community of more than 200,000 experts from 20 countries. In Innocentive’s “Challenge Platform” model, intellectual property (IP) is transferred from the solver to the “seeker” in return for a financial reward. In contrast, with Bayer Healthcare’s Grants4Targets, IP remains fully with the applicants initially, and subsequent collaborative agreements are negotiated for promising agents. In yet another crowdsourcing model sponsored by the UK’s Medical Research Council, IP is jointly owned and revenue is split between the parties.

Drs. Lessl and Asadullah write that in order for drug discovery crowdsourcing to be successful, “it is critical that the questions or challenges to be addressed are suitable, precisely defined and clearly presented, and that what is expected from potential solvers and offered by the searching organizations is clearly communicated.” Indeed, the expectation is clearly spelled out for the JDRF/InnoCentive initiative: “What we need is a sophisticated insulin that will take the guesswork out of managing diabetes by working the same way insulin works in people without diabetes,” Aaron Kowalski, Ph.D., assistant vice president of Treatment Therapies at JDRF, said in a press statement.

This isn’t JDRF’s first support of research on glucose-responsive insulin. Back in 2008, JDRF formed a $1 million partnership with a company called SmartCells, Inc. to advance the preclinical development of a product called SmartInsulin. SmartCells has since been acquired by Merck, which is continuing the product’s development. As Dr. Kowalski told me, “JDRF remains interested and excited in the clinical development of SmartInsulin by Merck.”

Photo by Miriam E. Tucker

So why is JDRF now simultaneously crowdsourcing the concept? Again, it’s about that wide net. First, Dr. Kowalski said, there may be multiple innovative ways to design glucose-responsive insulins. Second, it’s possible that not all insulin-dependent diabetes patients would respond the same way to a single type of insulin. “Therefore, we aim to stimulate more approaches that we hope will provide multiple options to patients with diabetes.”

Third, because the approval process for new drugs is highly variable, “The more options that are available, the more likely it is that one of them will make its way through the regulatory process.” Bottom line: “Insulin-dependent diabetes remains an urgent, unmet medical need, and it is important for JDRF to take a multi-pronged approach to tackle this challenge.” By opening up the challenge to the entire world, crowdsourcing would seem to be the ultimate “multi-pronged” approach.

Anyone with a solution that fits the proposed criteria is eligible to enter the Challenge, which requires only a written proposal. Submissions will be accepted through November 9, 2011.

It’s the conundrum of every clinician who cares for patients with diabetes: How do you keep them engaged and motivated in their self-care during the gaps between office visits? The findings of a study from an established multimedia company may point to one solution.

Launched in 2004 as the only national television show exclusively about diabetes, “dLife” is also an interactive website/online community, a radio show, a mobile app, and a resource for diabetes educators. Now, the company has sponsored a study that demonstrated measurable benefit from a tailored, 24-hour online intervention for people with type 2 diabetes.

Commissioned by dLife with an unrestricted grant to the Geisinger Health System, the study — officially called Technology in Diabetes Engagement and Self-Care (TIDES) — enrolled 166 adult type 2 diabetes patients identified via electronic medical records at three of Geisinger’s primary care sites. They were randomized to usual care or that plus unlimited use of a tailored online portal containing weekly diabetes self-care topics, Q&A with experts, quizzes, recipes, diet assistance, videos of segments from the television show, and social networking forum. Motivational messages were displayed throughout.

Participants received weekly email newsletters highlighting the site’s features. The site was available 24/7, so patients could use it as often as they wanted on their own schedule.

Over 6 months, 76% of the 117 in the intervention group were “engaged” in the site, opening the emails/links, and/or taking the quizzes. At 6 months, those randomized to the site improved in 9 of 11 variables on the Diabetes Knowledge Questionnaire, compared with no change in the controls. Change in the score was significantly correlated with the degree of site usage, according to Geisinger’s Dr. Margaret Rukstalis, who presented the findings at the recent meeting of the American Association of Diabetes Educators.

Although there was no overall difference at 6 months in median change from baseline in hemoglobin A1c between the intervention group and controls, the difference was significant among those who experienced a drop in A1c, by 0.8 percentage points compared with just 0.3 for the controls.

Dr. Rukstalis said that she believes the intervention filled a gap in clinical care. “Given many rural persons with diabetes are often medically underserved with limited access and ability to attend traditional lifestyle interventions, TIDES demonstrates how multimedia engages persons with diabetes via email and web in their own lives.”

Miriam E. Tucker/Elsevier Global Medical News

The founder/CEO of dLife, Howard Steinberg, told me that the company plans to introduce the intervention to health plans, provider groups and employers, and that it will be available in various forms over time. Meanwhile, elements of TIDES are available right now at dLife.com.

According to Mr. Steinberg, “We plan on studying the impact TIDES will have on improving practice efficiency, as it is low cost and requires little or no time from them. Doctors can feel confident that dLife is evidence based, effective and engaging.”

The international noncommunicable disease movement has hit a snag. Negotiations have been delayed in drafting the official Political Declaration for the United Nations High-Level Meeting on the Prevention and Control of NCDs, scheduled for Sept. 19-20. The main issue, according to the NCD Alliance, a lobbying coalition of global NCD-related organizations, is that the United States, Canada, and the European Union are blocking proposals for the inclusion of the specific goal of cutting by 25% all preventable deaths from cancer, cardiovascular disease, diabetes, and chronic respiratory disease by 2025.

In a statement, the alliance said “The situation is urgent. Yet, it is reported that sound proposals for the draft Declaration to include time-bound commitments and targets are being systematically deleted, diluted and downgraded.” The alliance has sent a letter to UN Secretary-General Ban Ki-moon to express “grave concern at the current state of preparations” for the high-meeting, which is to be only the second-ever such UN meeting focusing on a global health issue. The first one, on HIV/AIDS in 2001, is credited with spurring global political, social, and financial action to address that problem.

According to the alliance, language about “action-oriented outcomes” is being replaced with “vague intentions” to “consider” and “work towards” NCD reduction goals, moves they deem “simply unacceptable.” Along with the 2025 goal, the letter reiterates previous demands that UN member states must develop a set of specific, evidence-based targets and global indicators, a clear time line for tackling the epidemic of the four major NCDs, and “a high-level collaborative initiative of government and UN agencies with civil society to stimulate and assess progress.”

In an interview with Reuters, NCD chair Ann Keeling said that money was the main sticking point, with wealthier nations reluctant to commit to paying for chronic disease care in poor countries at a time when even “rich” economies are in a downturn. Indeed, the sum is considerable, as NCDs now account for 63% of all deaths worldwide and half of all global disability, posing a serious threat to development in many lower-income nations. “The reason we called for a UN summit in the first place was to move toward a global action plan…The world is essentially sleepwalking into a sick future,” said Ms. Keeling, who is also chief executive officer of the International Diabetes Federation.

Negotiations on the Political Declaration are set to resume Sept. 1. In the meantime, the IDF has recently launched a postcard campaign urging President Obama to attend the high-level meeting, which is expected to draw heads of state from many UN member nations. The IDF has also organized a rally – with the support of several U.S.-based diabetes organizations and bloggers and other international NCD-related groups – to be held in New York City’s Central Park on Sunday, Sept. 18 to raise public awareness about the worldwide impact of NCDs.

A phenomenon that was virtually impossible just a couple of decades ago is now becoming increasingly commonplace: Athletes with type 1 diabetes are not only competing at elite levels in just about every sport, but in many cases are actually beating nondiabetic competitors. Gary Hall Jr. won three Olympic Gold medals in swimming after his diagnosis in 1999. Natalie Strand, an anesthesiologist, won the TV extreme-sport reality show Amazing Race with her partner last December. And bicycle racers Team Type 1 won the Race Across America in 2009 and 2010.

Of course, exercise is encouraged for people with both type 1 and type 2 diabetes as a way of improving glycemic control, cardiovascular health, and quality of life. But in competitive sports, milliseconds count and physical perturbations of any kind can mean the difference between winning and losing. With type 1 diabetes, aerobic exercise can result in hypoglycemia, while anaerobic exercise can cause glucose levels to rise. Many sports involve a combination of the two. The athlete with type 1 diabetes must perform frequent glucose checks and eat or take insulin as needed to maintain normal or near-normal glucose, while at the same time performing the athletic feat itself. It seems nearly impossible, yet they do it … with the help of both new technology and devoted health care professionals.

“I take each athlete, learn their sport and find solutions,” said Dr. Anne Peters, the endocrinologist who managed Gary Hall Jr.’s diabetes regimen during the Olympics and is now doing the same for professional racecar driver Charlie Kimball. “Each athlete is unique and requires individualized care.”

Javier Megias of Team Type 1 checks his blood sugar while warming up for a time trial at a race in Italy. Photo courtesy of Team Type 1

New research is aimed at understanding the physiology of these athletes better in order to improve that care. Team Type 1, sponsored by Sanofi, is funding a study in which data are being collected on about 10 bike racers with and 10 without type 1 diabetes. The athletes are being evaluated before, during, and after races using continuous glucose monitors and devices placed on the bicycles that measure variables such as power, heart rate, energy expenditure, speed, and altitude. Data on the athletes’ diet, insulin doses, and other variables are also being collected in a total of five major cycling events, each of which includes 4-8 individual races. “Bottom line, it’s a lot of data,” said Team Type 1 director of research Dr. Juan Frias.

Interestingly, blood glucose values of up to 200 mg/dL – far above “normal” – have been recorded in the nondiabetic riders during very intense portions of races. This “stress hormone” effect had been seen previously in the lab and in some hospitalized patients, but has not been well documented in field-based, real-world studies of healthy people. “Ultimately we hope that this feasibility study will provide data that will help us begin to better understand the optimal glucose concentrations needed to maximize athletic performance, Dr. Frias said.

Findings from the TT1 study will likely be announced at scientific conferences during 2012 and ultimately published, he told me.

Another research project, led by Nate Heintzman, Ph.D., of the University of California, San Diego, is studying athletes who are part of Insulindependence, an organization that promotes physical fitness and sport for people with type 1 diabetes. One of Insulindependence’s recreation-specific clubs, Triabetes, trains people with type diabetes to compete in triathalons. The UCSD-supported project, called the Diabetes Management Integrated Technology Research Initiative (DMITRI), is looking at many of the same variables as in the TT1 study, but is also collecting other data, including behavioral and cognitive information and biospecimens for DNA sequencing.

Insulindependence Captains starting their track workout at UCSD in June. Every person in this photo has type 1 diabetes. Courtesy of Nate Heintzman, Ph.D.

“The idea is to use emerging wireless and device technology as well as genetics and genomics to understand more about the personalized basis of blood glucose management. I think we’ll uncover trends to help tailor therapeutic regimens, and also develop technology on a personal level,” Dr. Heintzman said.

The DMITRI project began in June, and data will begin to emerge in the coming months. In the meantime, if you’re a health care provider or person with diabetes interested in learning more, Dr. Peters recommends Sheri Colberg-Ochs Ph.D.’s Diabetic Athlete’s Handbook. And if you’re seeking inspiration, you can follow Team Type 1 founder and CEO Phil Southerland’s efforts to enter the team in the 2012 Tour de France, professional cycling’s most elite event.

Bottom line, according to Dr. Peters, “The truly gifted athletes I have known seem to be born with an ability that compels them to compete, diabetes or not.”

Are most health care providers attuned to the needs of their diabetes patients who are lesbian, gay, bisexual, and transgender (LGBT)? Does it matter? No and yes respectively, according to certified diabetes educator Theresa Garnero.

Rauchdickson photo via Flickr Creative Commons

More than half of medical school curricula include no information about LGBT people, and most multidisciplinary professionals have not received tools to care for LGBT individuals, Ms. Garnero said at the annual meeting of the American Association of Diabetes Educators.

A number of factors that increase the risk for developing diabetes are highly prevalent among people who are LGBT. For example, obesity and polycystic ovary syndrome (PCOS), both strong risk factors for type 2 diabetes, are more common among lesbians than among heterosexual women. Indeed, in one study, PCOS was identified in 38% of lesbians vs. just 14% of heterosexual women.

Antiretroviral drugs used to treat HIV/AIDS often lead to insulin resistance and type 2 diabetes. Men on HIV treatment have four times the risk of diabetes as do HIV-negative men. Moreover, cigarette smoking, alcohol abuse, and illicit drug use, all of which particularly endanger the health of those with diabetes, are frequent behaviors among LGBT individuals.

Depression is common in both LGBT individuals and people with diabetes. Withholding of insulin among closeted LGBT youth with type 1 diabetes could be a suicidal gesture rather than diabulimia.

How many LGB people have diabetes? It’s extremely difficult to obtain statistics – and there are virtually none for transgendered people – but based on self-reported health data, roughly 1.3 million LGB people have diabetes, a number approximately equal to that of type 1 or gestational diabetes, Ms. Garnero said.

So why does it matter? Lack of awareness and presumption of heterosexuality can lead to mistakes that alienate patients, such as lecturing a young lesbian with diabetes about the need for birth control or expressing negative attitudes toward patients who want to bring their same-sex partners to diabetes-education classes.

Importantly, patients who perceive that they can’t be open with their health care provider about sexual orientation may be reluctant to share other health-related information.

“Individuals who approach the health care system are already vulnerable from their illness … Intolerance is the last thing anyone wants when seeking health care. It is certainly not a part of the caring diabetes professional culture,” Ms. Garnero said.

What can the health care provider do? Placing a rainbow flag sticker or nondiscrimination statement that specifically mentions sexual orientation in the waiting room is a simple way providers can let patients know that they are LGBT-friendly. Other helpful information for providers can be found here.

Bottom line, she said: “All people with diabetes deserve the benefit of our expertise and access to ongoing support.”

Which is more effective in helping people who are at high risk for diabetes avoid the disease: a face-to-face “lifestyle intervention”? An Internet-based version? The same thing on a DVD? Or letting patients choose the version they want to pursue? And when you factor in the costs, which one is most cost-effective?

The prospective Rethinking Eating and ACTivity (REACT) study enrolled 434 overweight adults with abdominal obesity in eight rural communities in southwestern Pennsylvania. Already I’m thinking, not exactly Silicon Valley, but what do I know about their technological experience?

Participants were randomized to one of four groups with various versions of a “group lifestyle balance” program that aimed to educate them about physical activity, weight loss techniques, and other ways to make healthy changes to their lifestyles. The face-to-face version (119 people) involved weekly group education sessions for 12 weeks. The 113 participants in the DVD group watched 12 group lifestyle balance sessions on DVD and met with healthcare workers four times for debriefing about the DVDs. The Internet group (101 people) experienced 12 group lifestyle balance sessions that were incorporated into an online format with blogging and e-mail capabilities.

The final 101 participants were randomized to a “self-selection” group that allowed each person to decide which format to use. Sixty percent chose the Internet program, 40% chose face-to-face group meetings, and not a single person picked the DVD. (Sign of the times? I think I’ll put my CD/DVD shelves on eBay before they become worthless.)

The good news is that all versions of the lifestyle intervention worked, said Shihchen Kuo of the university’s department of epidemiology, who focused on a cost-effectiveness analysis. Elsewhere at the meeting, his associates presented separate analyses of 6-month follow-up data suggesting that letting patients choose the type of program provided the best outcomes. Participants in the self-selection group showed the largest improvements in physical and mental functioning and were 1.5 times less likely to have impaired fasting glucose compared to the other groups, though at least half of each group met the goal of losing 5% of their weight. Among those who lost weight, 80% kept it off at the 6-month follow-up, according to a university press release.

But effectiveness is only half the story when setting policy. Cost is the other half. Using preliminary data from the first 3 months of follow-up to model results at 3 and 5 years, the face-to-face program dominated the others in cost-effectiveness, Mr. Kuo reported. Adherence rates were 76% in the face-to-face program, 57% with the DVD, 53% in the self-selection group, and 38% using the Internet. The Internet-based program cost the most to operate, he said.

Projected out to 5 years, the face-to-face program would cost $63,377 per quality-adjusted life year compared with no intervention, he estimated, well within the range of many commonly accepted medical interventions.

It will be interesting to see if the cost-effectiveness results change when considering 6-month outcomes and become more closely aligned with the 6-month results for effectiveness. For now, though, “the face-to-face group lifestyle balance strategy delivered in rural communities is a sound investment” when choosing between the three models, Mr. Kuo concluded, “and appears to be economically reasonable” compared with doing nothing.

For those of you keeping score at home, I’d call this a tie — Humans 1, Technology 1. Would you agree?

Like the unstoppable tide of aging Baby Boomers and the worldwide flood of obesity-related problems, the burden of diabetes is expected to hit tsunami proportions. The number of people with diabetes hasn’t crested yet, but there already may be more people “under water” than expected.

Photo by Sherry Boschert

While the World Health Organization suggests that more than 220 million people around the world have diabetes, and one study estimated 285 million people had diabetes in 2010, a more recent analysis calculated that 347 million people worldwide have diabetes, investigators reported in The Lancet. That’s more than double the 153 million cases worldwide 3 decades ago.

Type 2 diabetes typically begins in middle age, so aging populations play a role, as do rising rates of obesity, a major risk factor for the disease. Using the World Health Organization’s more conservative numbers, an estimated 3.4 million people died in 2004 from problems related to diabetes, 80% of them in low-income and middle-income countries.

It’s no wonder that I heard languages from all over the world being spoken at the American Diabetes Association (ADA) annual scientific meeting. The 17,600 attendees were invited to place push-pins on a world map to show where they’d come from. Some did, providing a snapshot of the international participation in the meeting.

Photo by Sherry Boschert

Affluent countries whose physicians can more easily afford international travel to the meeting are more heavily represented, but the map still gives the impression of one world fighting a common disease. The keys to preventing or slowing diabetes are known and well shared — don’t smoke, eat a healthy diet, be physically active regularly (like 30 minutes of brisk walking 5 days per week), and maintain a normal body weight. If there’s one solution to this one-world problem, it may lie in finding a way for people of all nations to follow that advice.

Easier said than done. But as a major study presented at the meeting calculated, treating people at high risk for diabetes in the United States by either enrolling them in a lifestyle intervention program (to change eating and exercise habits) or by prescribing the drug metformin was extremely cost-effective compared with doing nothing.

Teaching people to “swim,” as it were, or throwing them a pharmaceutical life jacket, may be cheaper and better than expecting them to surf a tsunami.